The use of catheters to inject fluid into and drain fluid from a body cavity, vessel, canal, passage or duct of a patient is well-known. For urine drainage, the most commonly used catheter is the Foley catheter, named for its inventor. Certain patients may be catheterized with a Foley catheter to drain urine from the bladder through the urethra. In such a procedure, a catheter is inserted through the urethra until the distal end of the catheter is located in the bladder, after which a balloon adjacent the distal end of the catheter is inflated through an inflation lumen to retain the catheter in the patient. The proximal end of the catheter extends outside the patient's body and is usually connected to a drainage tube leading to a drainage bag. Urine passes through an opening or drainage eye adjacent the distal end of the catheter, through the drainage lumen extending through the catheter, and into the drainage tube to the bag for collection therein.
Foley catheters are generally sterile rubber or silicone tubing and are designed for insertion into the urethral meatus of the penis or vagina for the purpose of draining the urinary bladder. The Foley catheter is inserted until the catheter tip reaches the bladder and urine return is achieved. Once urine is draining through the tubing, sterile water, gas, or other fluid is pushed into a side port of another separate but attached tubing (or lumen) to inflate an external balloon proximate the tip of the catheter inside the bladder to anchor the catheter in the bladder. Currently there is no way of deflating the balloon, except by manually connecting a syringe to the port and removing the fluid.
Anchoring the catheter insures that the device stays in place while performing the desired function and it is also helpful in preventing intentional and/or accidental removal of the catheter. While anchoring the catheter is helpful in preventing its removal, removals do still occur. The removal of anchored catheters presents a serious risk of injury to patients.
An enormous number of urinary catheters are used daily in the United States. It is estimated that approximately 10 to 15 percent of patients admitted to the hospital receive a Foley catheter. Currently, if the balloon affixed to the Foley catheter is manually extracted while inflated, the balloon often tears the urethral mucosa causing strictures (scarring), bleeding, and infections. There have been numerous occasions when patients have self-extracted their catheters with the balloon fully inflated. Significant damage occurs to the urinary tract when such events occur.
A need exists for a safety device that attaches to a catheter that allows for the rapid release of pressure in the anchoring or attachment structures in order to minimize the risk of injury to patients when the catheters are forcibly removed.